NDC 63162-508

Balamine DM Syrup

Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide

Balamine DM Syrup is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Ballay Pharmaceuticals, Inc.. The primary component is Chlorpheniramine Maleate; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID63162-508_34f2008d-8ed5-4ef7-8c03-c8fd56d77d93
NDC63162-508
Product TypeHuman Otc Drug
Proprietary NameBalamine DM Syrup
Generic NameChlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2013-04-23
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameBallay Pharmaceuticals, Inc.
Substance NameCHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength2 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63162-508-20

6 BOTTLE in 1 TRAY (63162-508-20) > 20 mL in 1 BOTTLE
Marketing Start Date2013-04-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63162-508-16 [63162050816]

Balamine DM Syrup LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2013-04-23
Inactivation Date2019-11-27

NDC 63162-508-20 [63162050820]

Balamine DM Syrup LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-12-30
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/5mL

OpenFDA Data

SPL SET ID:9bae052a-2e3f-43c0-bf20-6f2cdf6f1ae5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1363752
  • NDC Crossover Matching brand name "Balamine DM Syrup" or generic name "Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    63162-508BalamineChlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide
    49963-118BronkidsChlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide

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